OBJECTIVE: The handmade expanded polytetrafluoroethylene (ePTFE) trileaflet-valved conduit could potentially be used as a substitute pulmonary valve replacement material, especially in children. The current study investigated (1) the function of the ePTFE trileaflet-valved conduits in an ex vivo experimental system and (2) the short-term performance of the conduit in a porcine model to verify its clinical applicability. METHODS: The competency of the ePTFE trileaflet-valved conduits was estimated through ex vivo (using a pulmonary mock circulation loop) and in vivo (in a porcine model with a damaged pulmonary valve) experiments. Explants were examined by gross morphology and histopathologic examination. RESULTS: In the ex vivo experiment, the ePTFE trileaflet-valved conduits were determined to effectively increase mean pulmonary pressure from 10.2 to 14.4 mm Hg compared with defective silicon-valved conduits. In addition, the regurgitation fraction value of ePTFE trileaflet-valved conduits was 15.9% to 18.1%, which was significantly better than the defective valve conduits (regurgitation fraction = 73.5%-85.7%). In the in vivo experiment, the valved conduits were confirmed to be with good valve position maintenance, and the valve and leaflets showed no signs of thickening or peeling after a short-term implantation period. There were also no significant signs of inflammation reaction on histopathologic examination. CONCLUSIONS: The ePTFE trileaflet-valved conduits for pulmonary valve reconstruction showed acceptable performance and outcomes in the ex vivo and in vivo experiments. The ePTFE trileaflet-valved conduit may be clinically useful, although additional studies in animals should be conducted to determine its long-term outcomes.

1st Faculty of Medicine Charles University Prague Czech Republic

Department of Electrical Engineering Kao Yuan University Kaohsiung Taiwan

Department of Engineering and Maintenance Kaohsiung Veterans General Hospital Kaohsiung Taiwan

Department of Pediatrics National Cheng Kung University Hospital College of Medicine National Cheng Kung University Tainan Taiwan

Division of Cardiovascular Surgery Department of Surgery National Cheng Kung University Hospital College of Medicine National Cheng Kung University Tainan Taiwan

Heart Science and Medical Devices Research Center National Cheng Kung University Tainan Taiwan

J Thorac Cardiovasc Surg. 2018 Feb;155(2):775-776. doi: 10.1016/j.jtcvs.2017.10.048. PubMed

J Thorac Cardiovasc Surg. 2018 Oct;156(4):1639-1641. doi: 10.1016/j.jtcvs.2018.05.034. PubMed

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